Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

A new 510(k) pathway for demonstrating substantial equivalence to an existing medical device can be expected to come out of CDRH as early as Q1 2018.

As part of developing the new voluntary and alternative 510(k) pathway, the FDA is also drafting new guidance on “acceptable levels of uncertainty” to establish a balance between the collection of pre-market and post-market data for approving premarket submissions of devices.

The FDA’s regulatory process for manufacturers of new moderate-risk devices has “remained largely unchanged since it was first implemented 40 years ago,” Commissioner Scott Gottlieb said in a blog post announcing the agency’s intent to issue the draft guidances.

The existing framework for 510(k) submissions is failing to reflect the innovation that the agency is seeing today with certain medical technologies, and to “realize the full potential of the FDA’s consensus standards program,” Gottlieb said.